Comparing the Efficacy of Traditional Buddhist Mindfulness Training Versus Secular Mindfulness-based Cognitive Therapy for Residual Depressive Symptoms in Patients With Depressive Disorders: a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Depressive symptom severity
研究概览
简要总结
This interventional study is conducted with the goal of comparing the efficacy of traditional Buddhist mindfulness training versus secular mindfulness based cognitive therapy among patients with depressive disorders. We are also interested in studying how these interventions compare in terms of preventing further relapses of depression. Additionally, this study aims to identify factors that influence the efficacy of this intervention, such as self-report mindfulness, self-compassion, and religiosity.
详细描述
This study has the following objectives:
- To investigate whether traditional Buddhist mindfulness training is non-inferior to secular MBCT in reducing depressive symptoms and improving psychological wellbeing (primary outcomes)
- To compare the effectiveness of the two interventions on self-compassion, mindfulness, and spirituality/religiosity (secondary outcomes)
- To investigate whether self-compassion, mindfulness, and spirituality/religiosity mediate the effectiveness of the interventions
- To investigate whether baseline spirituality/religiosity moderates the effectiveness of the interventions
- To compare the effectiveness of the two interventions in preventing depressive relapse over 6 months and 12 months.
This will be a parallel group, randomized controlled trial conducted at Colombo North Teaching Hospital (CNTH), and the Faculty of Medicine, University of Kelaniya and involves interventions conducted over 4 months, followed by 12 months of follow-up. Patients with a history of depressive disorder will be recruited from the Psychiatry Clinic, Colombo North Teaching Hospital. Sample size, calculated for a non-inferiority trial design, is 30 in each group. Simple randomization and allocation concealment using sequentially numbered, opaque, sealed envelopes will be used. Both groups will undergo interventions over 8 weeks, with weekly 2-hour sessions. One group will undergo the novel intervention, i.e., traditional Buddhist mindfulness training. The other group will undergo MBCT. Primary outcomes will be depressive symptom severity (Beck Depression Inventory-II), Psychological wellbeing (WHO-5 Wellbeing Index), and the depressive relapse rate at 6 months and 1 year after completion of intervention. Secondary outcomes include mindfulness (Six-Facet Mindfulness Questionnaire), Self-compassion (Self-compassion scale - short form), Spirituality/religiosity (BENEFIT scale), and Acceptability/feasibility. To establish non-inferiority, the 95% CI of the mean difference will be compared against the non-inferiority margin. Moderator and mediation analyses will be conducted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
As the study involves two psychological/behavioural interventions, it will not be possible to mask the participants, care providers or the investigators. However, most outcomes are based on self-report ratings, and the outcome at the end of the intervention (relapse of depression) will be assessed using telephone interviews by investigators blind to the participant's study arm.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or above
- •Buddhist faith (Only Buddhists are selected as one of the interventions involves Buddhist teachings, and any recruited participant has a probability of being enrolled in the Buddhist mindfulness intervention)
- •A history of one or more episodes of moderate or severe depression
- •Currently having BDI-II score > 13, i.e., mild to moderate depressive symptoms
排除标准
- •Currently having a severe depressive episode, according to the Composite International Diagnostic Interview (CIDI) Sinhalese version
- •Currently having moderate to severe suicidal ideation (according to CIDI)
- •Recent changes in antidepressant medication
- •Unable to understand and communicate in Sinhalese
结局指标
主要结局
Depressive symptom severity
时间窗: Baseline (T0), Post-intervention (T1) 8 weeks from baseline
Beck Depression Inventory -II Score
Psychological wellbeing
时间窗: Baseline (T0), Post-intervention (T1) 8 weeks from baseline
WHO Wellbeing Index - 5 score
Relapses of depression
时间窗: At 6 months and 1 year after completion of intervention
Depressive relapse rate assessed using Composite International Diagnostic Interview
次要结局
- Self-compassion(Baseline (T0), Post-intervention (T1) 8 weeks from baseline)
- Self-report mindfulness(Baseline (T0), Post-intervention (T1) 8 weeks from baseline)
- Spirituality/religiosity(Baseline (T0), Post-intervention (T1) 8 weeks from baseline)
研究者
Anuradha Baminiwatta
Lecturer
University of Kelaniya